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Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral
capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the
relationship at the recommended phase II dose between thymidine synthase and thymidine
phosphorylase expression and tumor response and/or toxic effects in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily
every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks
beginning on day 1. Treatment continues for at least 2 courses in the absence of disease
progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated
in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including but not limited
to breast, gastrointestinal, and unknown primary cancer that is refractory to standard
therapy or for which no standard therapy exists No known bone marrow involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR
WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 Hepatic: Bilirubin no
greater than 1.5 mg/dL No known Gilbert's syndrome No other significant hepatic disease
requiring medication Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No
significant cardiac disease requiring medication Other: Not pregnant or nursing Fertile
patients must use effective contraception No other significant medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior colony
stimulating factor and other cytokines active on bone marrow Chemotherapy: At least 4
weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No prior or
concurrent irinotecan and fluorouracil therapy Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy
Surgery: Recovered from prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sridhar Mani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IIIB breast cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • stage IV anal cancer
  • recurrent anal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • recurrent esophageal cancer
  • regional gastrointestinal carcinoid tumor
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • small intestine adenocarcinoma
  • small intestine lymphoma
  • small intestine leiomyosarcoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • unspecified adult solid tumor, protocol specific
  • newly diagnosed carcinoma of unknown primary
  • carcinoma of the appendix
  • recurrent carcinoma of unknown primary
  • stage IV pancreatic cancer



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461